Manual bone anchor placement devices

ABSTRACT

Manual bone anchor placement devices include a lever, a force translator and a rotary force mechanism. The devices are substantially gun- or pistol-shaped and are actuated when a user squeezes the lever to the gripping portion of a handle. Manual, linear force on the lever is mechanically translated through the force translator to the rotary force mechanism which transmits a rotary force to a securing element, or coupler, which mates with a bone anchor screw. The rotation of the securing element or coupler applies a torque on the bone anchor screw thereby placing the screw into bone. Kits comprising any of: a molded flexible sleeve for enclosing a suture, a retaining clip for preventing the suture from slipping out of the sleeve, a buttress-shaped bone anchor screw comprising a micropolished eyelet for receiving a suture, and a suture which may, or may not be pre-attached to the bone anchor screw, are disclosed. A collapsible, protective cover for a bone anchor screw is also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This relates to, and claims the benefit of and priority to, provisionalU.S. patent application Ser. Nos. 60/085,113, filed May 12, 1998, and60/125,207, filed on Mar. 18, 1999. The entirety of these provisionalapplications is hereby incorporated herein by reference.

TECHNICAL FIELD

This invention relates to devices for manually placing or implantingbone anchor screws into bone and to methods of using these devices.

BACKGROUND INFORMATION

In elderly women, the bladder and proximal urethra tend to descend fromtheir normal anatomic positions such that the bladder neck and proximalurethra move away from the posterior wall of the pubic bone, producing acondition known as stress urinary incontinence (SUI). This condition maybe treated surgically, using sutures to fasten periurethral tissue tothe pubic bone as a means of repositioning and resuspending the bladderand proximal urethra. The sutures are anchored to the pubic bone usingbone anchor screws.

Bone anchor placement devices, such as bone anchor drivers, may be usedto place a bone anchor screw at a selected insertion site in the bone.Either percutaneous or transvaginal surgical procedures may be performedusing such devices. Percutaneous procedures require an incision in theabdominal wall and/or anterior vaginal wall in order to introduce thebone anchor placement device and are necessarily invasive and traumaticto the patient. Transvaginal such procedures are cost-limiting and maynot be readily available when required to perform surgery. Typical boneanchor placement devices used in transvaginal procedures are configuredlike power drills and are cannulated.

A suture may be threaded into a bone anchor screw prior to, or after,its insertion into the pubic bone. Load on a suture at the point ofattachment of the suture to the bone anchor screw can cause breakage ofthe suture requiring additional, undesired surgery.

SUMMARY OF THE INVENTION

The present invention relates to manual bone anchor placement devices.The manual bone anchor placement devices disclosed herein areparticularly useful in transvaginal methods of treating female urinaryincontinence, although they can be used in other medical applications.The devices of the present invention are designed to permit rotationalinsertion of a bone anchor screw and to provide low cost alternatives topowered cannulated drills. The devices may be disposable or may bemodular in nature, thereby allowing interchange of parts for reuse.

An advantage of the disclosed manual bone anchor placement devices isthat they eliminate the need for a percutaneous incision to access aninsertion area, although the devices can be used in a percutaneousprocedure. A transvaginal approach to inserting a bone anchor screw intothe pubic bone is far less invasive than a percutaneous procedure, thusa transvaginal procedure is far less traumatic for the patient.

An additional advantage of the disclosed manual bone anchor placementdevices is that they seat a self-tapping bone anchor screw with apre-attached suture. Since the bone anchor screw used with the discloseddevices is self-tapping and the suture is pre-attached, it isunnecessary for the physician to prebore a hole into the bone, removethe drill, introduce a seating device, seat the bone anchor screw, andthen thread the suture. Single-step insertion of the bone anchor screwand suture not only reduces the total time required for the procedure,it also greatly reduces the possibility that the physician may loseaccess to the bored hole or seated bone anchor screw. Thus, the possibleneed to drill additional holes and/or seat additional bone anchor screwsis reduced.

The manual bone anchor placement devices disclosed herein provide amechanism to translate linear force exerted by a user on a lever intorotary force on a bone anchor screw. In one aspect of the invention, themanual bone anchor placement device comprises a manually-actuatablelever, a resilient element, a force translator, and a rotator. The forcetranslator is coupled at its distal end to the lever and at its proximalend to the resilient element. The resilient element is coupled to therotator. Linear force on the lever is transmitted through the forcetranslator to the resilient element and from the resilient element tothe rotator. The rotator rotates in response to this force. The devicemay further comprise a securing element coupled to the rotator whichmates with a bone anchor screw and rotates when the rotator rotates,thereby applying a torque on the bone anchor screw, placing the boneanchor screw into bone.

In another aspect of the invention, the manual bone anchor placementdevice comprises a manually-actuatable lever, a force translator, arack, and a rotator. The force translator comprises a distal end and aproximal end, the distal end receiving force from the lever, theproximal end being coupled to the rack. The force translator transmitsforce to the rack which moves linearly into an engaging position inresponse to this force. The rotator is positioned in close proximity tothe rack for engagement with the rack when the rack moves into theengaging position. Engagement of the rotator by the rack causes therotator to rotate. The device may further comprise a coupler coupled tothe rotator which mates with a bone anchor screw and rotates when therotator rotates, placing the bone anchor screw into bone.

In another aspect of the invention, a manual bone anchor placementdevice is disclosed which comprises a manually-actuatable lever, adriver rod comprising threads, and a cup and washer positioned over thethreads. The cup is coupled to the lever and moves axially along thedriver rod upon actuation of the lever, engaging with the washer. Whenthe cup and washer engage each other, linear force transmitted from thelever through the cup is translated to a rotary force on the driver rod,rotating the driver rod. The device may further comprise a couplingelement for mating with a bone anchor screw, and for rotating when thedriver rod rotates to place the bone anchor screw into bone.

The present invention also relates to a self-tapping buttress-shapedbone anchor screw. The bone anchor screw of the present inventioncomprises a micropolished eyelet for receiving a suture. The eyelet maybe circular, ellipsoidal, or tear-drop shaped. The bone anchor screwdescribed herein is designed to require less torque to seat and tominimize load on a pre-attached suture in comparison with known boneanchor screws.

Kits are also disclosed comprising any of: a molded flexible sleeve forenclosing a suture, a retaining clip for preventing the suture fromslipping out of the sleeve, a buttress-shaped bone anchor screwcomprising a micropolished eyelet for receiving a suture, and a suturewhich may, or may not, be pre-attached to the bone anchor screw. Acollapsible, protective cover for a bone anchor screw is also disclosed.

The foregoing and other objects, aspects, features, and advantages ofthe invention will become more apparent from the following descriptionand from the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis generally being placed upon illustratingthe principles of the invention.

FIG. 1A is a perspective side view of a manual bone anchor placementdevice within the scope of the present invention. FIG. 1B shows asection of a side-view of the shaft of a manual anchor placement deviceto which a suture ring is clipped and through which a suture isthreaded. FIG. 1C shows an enlarged cross-sectional view of a suturering.

FIG. 2 shows a perspective side view of a manual bone anchor placementdevice according to one embodiment of the present invention. In thisembodiment, the manual bone anchor placement device comprises a groovecut into the outer surface of the handle through which a suture isthreaded and the shaft of the manual bone anchor placement is angledupwards at a 90 degree angle.

FIG. 3A is a side view of a cross-section through a wrap-around manualbone anchor screw placement device according to one embodiment of theinvention showing the components of an action mechanism and awrap-around rotary force mechanism in which a resilient element iswrapped around a rotator. FIG. 3B is an enlarged perspective view of aconnector and lever arrangement in an action mechanism according to oneembodiment of the invention.

FIGS. 4A-D show views of the head end of a wrap-around manual boneanchor placement device in different embodiments of the invention. FIG.4A shows a cross-sectional view of an embodiment where the rotatorcomprises a floating pawl. FIG. 4B shows an enlarged cross-sectionalview of a rotator which comprises three floating pawls. FIG. 4C shows athree-dimensional cut-away view of the head end of the shaft in anembodiment of the invention where the rotator comprises two floatingpawls. FIG. 4D shows a three-dimensional cut-away view of the head endof the shaft in an embodiment of the invention where the rotatorcomprises a single floating pawl.

FIGS. 5A-H show enlarged views of securing elements used with awrap-around manual bone anchor placement device and bone anchor screwsaccording to different embodiments of the invention. FIGS. 5A-D showenlarged views of a securing element which comprises a Hex-shaped recessin its mating portion for mating with a bone anchor screw with aHex-shaped shaft at its base. FIG. 5A is a perspective view of thesecuring element showing the Hex-shaped recess. FIG. 5B is across-sectional view through the engaging portion of the securingelement. FIG. 5C is a perspective side-view of the securing element.FIG. 5D is a view from the top of the securing element. FIG. 5E shows abone anchor screw which comprises a Hex-shaped shaft at its base. FIG.5F shows a perspective view of a securing element whose mating portioncomprises a Hex-shaped protrusion. FIG. 5G shows a perspective side viewof a securing element whose mating portion comprises a Hex-shapedprotrusion. FIG. 5H shows an enlarged view of a bone anchor screw with aHex-shaped recess at its base for mating with a securing element whosemating portion comprises a Hex-shaped protrusion.

FIGS. 6A-C show enlarged views of the rotatable housing used in awrap-around manual bone anchor placement device. FIG. 6A shows aperspective view. FIG. 6B shows a side view. FIG. 6C shows across-sectional view.

FIGS. 7A-C show enlarged views of the floating portion of a floatingpawl used in a wrap-around manual bone anchor placement device. FIG. 7Ashows a perspective view. FIG. 7B shows a side view. FIG. 7C shows across-sectional view.

FIGS. 8A-C show enlarged views of the flat spring portion of a floatingpawl used in a wrap-around manual bone anchor placement device. FIG. 8Ashows a perspective view where the flat spring portion is slightly bent.FIG. 8B shows a side view of a flat spring portion which is slightlybent. FIG. 8C shows a perspective view where the flat spring portion islying flat.

FIG. 9 shows an enlarged view of a resilient element used in awrap-around manual bone anchor screw placement device.

FIG. 10 shows a schematic view of how force is transmitted through theresilient element in a wrap-around manual bone anchor placement device.

FIG. 11 shows a perspective view of a wrap-around manual anchorplacement device according to one embodiment of the invention where theshaft and handle portion comprise interchangeable modules.

FIGS. 12A-12I show enlarged views of a head module of a wrap-aroundmanual bone anchor placement device according to one embodiment of theinvention.

FIG. 13A shows an enlarged perspective view of a head module of awrap-around manual bone anchor placement device in one embodiment of theinvention where a protective sheath is provided to protect the boneanchor screw and the portion of the securing element which protrudesfrom the head module. FIG. 13B shows an enlarged perspective view of acollapsible protective cover for a bone anchor screw. The left-hand sideof the Figure shows the cover in an uncollapsed state. The right-handside of the Figure shows the cover in a collapsed state. FIG. 13C showsan enlarged cross-sectional view of a collapsible protective coversurrounding a bone anchor screw. The left-hand side of the Figure showsthe cover in an uncollapsed state and completely surrounding a boneanchor screw. The right-hand side of the Figure shows the cover in acollapsed state, exposing the bone anchor screw.

FIG. 14 shows an enlarged version of a securing element used in awrap-around manual bone anchor placement device according to oneembodiment of the invention where the mating portion of the securingelement may be uncoupled from the engaging portion of the securingelement.

FIG. 15 is a side view of a cross-section through a rack and rotatormanual bone anchor placement device according to one embodiment of theinvention, showing the components of an action mechanism and a rack androtator rotary force mechanism.

FIG. 16 shows an enlarged view of a head assembly in a rack and rotatormanual bone anchor screw placement device in which the rotator comprisesa ratchet wheel.

FIG. 17 shows an enlarged view of a head assembly in a rack and rotatormanual bone anchor placement device in which the rotator comprises apinion.

FIGS. 18A and 18B show a side view of a cross-section through the handleand proximal portion of the shaft in a rack and rotator manual boneanchor placement device according to one embodiment of the invention.FIG. 18A shows an action mechanism which transmits a pull force on aforce translator. FIG. 18B shows an action mechanism which transmits apush force on a force translator.

FIG. 19 shows an enlarged cross-sectional view of a head assembly in arack and rotator manual bone anchor placement device according to oneembodiment of the invention, in which linear force is transmitted to therack through a rack spring and the rotator comprises a pinion. A boneanchor screw pre-attached to a suture is shown coupled to the pinion bya coupler. The bone anchor screw is covered by a protective cover. Theportion of the bone anchor screw and pre-attached suture inside thecoupler is shown by dashed lines in the Figure.

FIG. 20 shows an enlarged cross-sectional view of a head assembly in arack and rotator manual bone anchor placement device according to oneembodiment of the invention in which linear force is transmitted to therack via wedge members.

FIG. 21 shows an enlarged cross-sectional view of a head assembly in arack and rotator manual bone anchor placement device according to oneembodiment of the invention in which linear force is transmitted to therack by pneumatic or hydraulic force on a plunger.

FIG. 22A shows a cross-sectional side-view of a cup and washer manualbone anchor placement device according to one embodiment of theinvention which comprises a cup and washer rotary force mechanism. FIG.22B shows a further embodiment of the invention in which a return coilspring is provided between the cup and washer assembly and the barrelend of the handle.

FIGS. 23A-D show an enlarged views of a cup and washer assembly used ina cup and washer manual bone anchor placement device according to oneembodiment of the invention. FIG. 23A shows a cross-sectional view of adriver rod comprising grooves to interface with protrusions on a washer.FIG. 23B shows a cross-sectional view of a washer with correspondingprotrusions to interface with the grooves in the driver rod. FIG. 23Cshows a perspective side view of a cup and washer assembly on a driverrod in which the washer is in a “free-floating” or non-engaged position.FIG. 23D shows a perspective side-view of a cup and washer assembly inwhich the washer is in an engaged position.

FIGS. 24A and 24B show an enlarged view of a cup and washer assemblyaccording to one aspect of the invention. FIG. 24A shows across-sectional view from one side of a cup and washer assemblypositioned on a driver rod which includes a cover plate. FIG. 24B showsa cross-sectional view from the top of the cup and washer assembly.

FIG. 25A shows a section of a lead anchor screw and a coupling elementused in a cup and washer manual bone anchor placement device accordingto one embodiment of the invention in which the coupling elementcomprises a recess through which the suture of a bone anchor screw isthreaded. The Figure shows the suture partly pulled out of the recess.FIG. 25B shows a perspective view of the top of a cover plate used in acup and washer assembly according to one embodiment of the invention.FIG. 25C shows a perspective view of the top of a washer used in a cupand washer assembly. FIG. 25D shows a perspective view of the top of acup used in the cup and washer assembly (i.e., the side which faces thewasher).

FIG. 26 shows a cross-section through a longitudinal axis of aself-tapping bone anchor screw according to one embodiment of theinvention.

DESCRIPTION

The manual bone anchor placement devices disclosed provide a mechanismto translate manually linear force (i.e., an operator's hand squeezing alever) into rotary force on a bone anchor screw. As used herein “placinga bone anchor screw” (or grammatical equivalents thereof) refers torotational action on, and/or screwing in, of a bone anchor screw intobone. Manual actuation of the disclosed devices occurs when the operatorsqueezes or pulls a lever with, for example, a single hand. Force on thelever is mechanically transmitted through a force translator to a rotaryforce mechanism. Each of the disclosed devices are distinguishable bythe type of rotary force mechanism used.

In one embodiment of the invention, a manual bone anchor placementdevice uses a rotary force mechanism which comprises a resilient elementwrapped around a rotator (“wrap-around manual bone anchor placementdevice”). In a second embodiment of the invention, a manual bone anchorplacement device (“rack and rotator manual bone anchor placementdevice”) uses a rotary force mechanism which comprises a rack androtator assembly. In a third embodiment of the invention, a manual boneanchor placement device uses a rotary force mechanism which comprises acup and washer assembly (“cup and washer manual bone anchor placementdevice”). A self-tapping bone anchor screw with a pre-attached suture isalso disclosed which may be used with any of the aforementioned manualbone anchor placement devices. All of the devices are useful in, forexample, transvaginal bone anchor screw insertion procedures.

Wrap-Around Manual Bone Anchor Placement Device

In the embodiment of the invention shown in FIG. 1, the manual boneanchor placement device 1 is substantially pistol- or gun-shaped. Inthis embodiment, the manual bone placement device 1 comprises a handle 2and a shaft 3. The handle 2 comprises a gripping portion 26 tofacilitate gripping by the user and a lever 4 through which the user maymanually transmit force to the bone anchor placement device 1.

As shown in FIG. 3A, the shaft 3 comprises a first end 3 a, proximal tothe handle 2, and a second end or head end 3 h, distal to the handle 2.A force translator 12 runs through the shaft 2 and transmits linearforce exerted manually on the lever 4 to a head assembly 35 positionedat the second end 3 h of the shaft 3 (shown enlarged in FIG. 4A). Thehead assembly 35 is capable of engaging with a bone anchor screw 5 andcomprises the mechanism which translates linear force from the forcetranslator 12 to rotary force on the bone anchor screw 5.

The shaft 3 is curved to facilitate correct placement of the bone anchorplacement device 1 to the proper bone anchor screw 5 insertion site. Theshaft 3 is generally linear at its proximal or first end 3 a and anglesupward near its head end 3 h. The upward angle can be from 0 to about135 degrees. In one embodiment of the invention, the upward angle isbetween about 75 and about 100 degrees. In another embodiment of theinvention, shown in FIG. 2, the upward angle is approximately 90degrees. In some embodiments of the invention, the shaft 3 can berotated 360 degrees relative to the handle 2 (see dashed arrow in FIG.1A).

As shown in FIG. 3A, the handle 2 of the manual bone anchor placementdevice 1 of the present invention may further comprise an actionmechanism through which force from the lever 4 is transmitted to theforce translator 12. The action mechanism comprises the lever 4, a pivot9, and the proximal end of the force translator 12. The force translator12 is connected to the lever 4 by a connector 11 which is positionedbeneath the pivot 9. The action mechanism further comprises a torsionalspring 10 which abuts the lever 4 in the handle 2.

In one embodiment of the invention shown in FIG. 3B, the connector 11comprises a “slot and pin arrangement.” In this embodiment, a slot 11 sis included in the portion of the lever 4 proximal to the pivot 9 anddefines openings in the sides, front, and back, of the lever 4. Aconnector member 11 m is configured to fit in the slot 11 s and furthercomprises a pinhole 11 h. The connector member 11 m is coupled to theforce translator 12 at the end of the connector member 11 m distal tothe pinhole 11 h. The connector member is positioned within the slot 11s and secured by a pin 11 p which extends through both the slot 11 s andthe pinhole 11 h.

In the embodiment of the invention shown in FIG. 3A, the lever 4 extendsat least partially from the handle 2 and linear force on the lever 4 isexerted by pulling on the lever 4. Because the pivot 9 is located abovethe connector 11, the translator 12 is subjected to tensile loading(e.g., a pulling force) during activation and compressive loading (e.g.,a pushing force) during release. The torsional spring 10 abutting thelever 4 thus forces the lever 4 into its original position for the nextstroke.

Force exerted on the lever 4 is translated as linear force through theforce translator 12. As shown in FIG. 3A, the force translator 12 is asubstantially linear member which extends from the handle 2 through theshaft 3 of the manual bone anchor device 1. The force translator 12 maybe rigid or flexible, so long as it is tensile. In one embodiment of theinvention, the force translator 12 is a wire. Additional types of forcetranslators 12 include, but are not limited to, a cable, a rod, suturematerial, a string, and the like. Suitable force translator 12 materialsinclude metal, plastic, polymers (e.g., nylon, in the case of suturematerials), copolymers, and the like.

In a further embodiment of the invention, washers 21 are positioned onthe inside of the shaft 3 to reduce the friction caused by the forcetranslator 12 contacting the inside surfaces of the shaft 3 (see FIG.4A). The washers 21 can be made of Teflon® material or any material witha low coefficient of friction.

The section of the shaft portion 3 which seats the head assembly 35 maybe simply a wider extension of the head end 3 h of the shaft 3 as inFIG. 3A. Alternatively, the head assembly 35 may be provided within ahead module 28 seated on the distal-most tip 3 b of the shaft (as inFIGS. 4A, 4C, and 4D, for example) and may be either integral with theshaft 3 or separable from the shaft 3. The head assembly 35 comprises arotator 14, a securing element 166, and a resilient element 13, shown inmore detail in FIGS. 4A-D. The resilient element 13 is coupled to bothforce translator 12 and the rotator 14. In one embodiment of theinvention, as shown in FIGS. 4C and 4D, the resilient element 13 is aconstant force spring which is welded to the end of the force translator12 which is proximal to the rotator 14.

Force is transmitted through the resilient element 13 to the rotator 14which rotates in response to this force. The rotator 14 comprises atleast one protruding portion 15 p, shown in more detail in FIGS. 4C and4D and is capable of frictionally and mechanically engaging with thesecuring element 166 (shown in more detail in FIGS. 5A, 5C, 5F, and 5G).The securing element 166 further comprises an enaging portion 16 and amating portion 6. The mating portion 6 of the securing element 166extends at least partly from the head end 3 h of the shaft 3, or thehead module 28, and mates with a bone anchor screw 5.

In the embodiment of the invention shown in FIGS. 4A-C, the rotator 14comprises at least one floating pawl and the engaging portion 16 ofsecuring element 166 has teeth 17 which are capable of meshing with theprotruding portion 15 p of the floating pawl and rotating in response tothe rotation of the pawl. The protruding portion 15 p extends from aflat spring member 15 s as shown in FIGS. 4C and 4D. The flat springmember 15 s may be angled or bent, as shown in more detail in FIGS.8A-C, to control the position of the protruding portion 15 p of thepawl.

It will be readily apparent to one of ordinary skill in the art that anynumber and type of protruding portions 15 p may be provided so long asthey are able to frictionally and mechanically engage with the engagingportion 16 of the securing element 166 to cause rotation of the securingelement 166. In the embodiment of the invention shown in FIG. 4B, therotator 14 comprises three floating pawls which are spaced equidistantfrom each other about a central axis of rotation. In another embodimentof the invention, shown in FIG. 4C, the rotator 14 comprises twofloating pawls, and the teeth 17 of the engaging portion 16 are designedto allow one-directional engagement with the pawls. Slip-free rotationof a bone anchor screw 5 is provided by this design.

In the embodiment of the invention shown in FIGS. 4C and 4D, the rotator14 is contained within a rotatable housing 18 positioned within the headmodule 28 and is fitted into at least one groove 22 within the innerwall of the rotatable housing 18. FIGS. 6A-C show enlarged views of therotatable housing 18. In the embodiment of the invention shown in FIGS.6A and 6C, the rotatable housing 18 comprises two grooves 22 toaccommodate a rotator 14 that comprises two floating pawls.

In the embodiment of the invention shown in FIGS. 4 A-D, the resilientelement 13 is at least partially wound around the rotatable housing 18,and the rotatable housing 18 and the rotator 14 move as one. Theresilient element 13 is secured to the rotatable housing 18 by theinsertion of an inwardly projecting tail 13t of the resilient element 13into a notch 25 in the rotatable housing 18. An enlarged view of theresilient element 13 and inwardly projecting tail 13 t is shown in FIG.9.

As shown schematically in FIG. 10, force transmitted through theresilient element 13 causes the inner diameter ID of the resilientelement 13, which is wrapped around the rotatable housing 18 todecrease, and the resilient element 13 to grip the rotatable housing 18,resulting in its rotation. Upon elimination of force on the resilientelement 13, the inner diameter ID of the portion of the resilientelement 13, wrapped around the rotatable housing 18 gets larger,resulting in free rotation in the opposite direction. The grippingaction in one direction and the slipping action in the oppositedirection provide the action needed to drive a bone anchor screw 5 intothe bone when a linear pull force is exerted on the lever 4.

In the embodiment of the invention shown in FIGS. 4C and 4D, thesecuring element 166 is positioned at least partially within therotatable housing 18, and the engaging portion 16 of the securingelement 166 rotates in response to the rotation of the rotatable housing18 and rotator 14.

As shown in the enlarged view of the securing element 166 provided inFIGS. 5A and 5C, the securing element 166 further comprises a generallycylindrical front piece 19, which extends from the engaging portion 16of the securing element and fits into a complementary recessed portion30 in the inner wall of the head end 3 h of the shaft portion 3 or thehead module 28 (shown in FIGS. 12A, 12B, and 12C). The front piece 19acts to position the rotatable housing 18 within the head end 3 h of theshaft 3, or within the head module 28 (as shown in FIGS. 12A-C),allowing it to rotate freely about the axis defined by the front piece19.

The mating portion 6 of the securing element 166 extends at leastpartially outside the head end 3 h of the shaft 3. The bone anchor screw5 may be seated on the mating portion 6 of the securing element 166 in avariety of ways and the mating portion 6 of the securing element 166 maybe fabricated to complement a variety of different types of bone anchorscrews 5. In one embodiment of the invention, shown in FIG. 5E, when thebone anchor screw 5 being used provides a shaft 5 a with a Hex-shape,the mating portion 6 of the securing element 166 is designed to providea recess 6 a that has a Hex-shaped cross-section (see FIGS. 5A, B andD). It will be readily apparent to one of ordinary skill in the art thatthe recess 6 a of the mating portion 6 of the securing element 166 maybe any type of shape (e.g., a T-shape or an X-shape) that allows forfrictional and mechanical engagement with a bone anchor screw 5 having ashaft 5 a with the corresponding shape. In a further embodiment of theinvention, shown in FIGS. 5F and 5G, the mating portion 6 of thesecuring element 166 comprises a shaft 6 b while the bone anchor screw 5(shown in FIG. 5H) provides a recess 5 b complementary to the shape ofthe shaft 6 b.

Any type of bone anchor screw 5 may be used adaptable to the matingportion 6 of a selected securing element 166. In one embodiment, shownin FIG. 1A, the bone anchor screw 5 has a pre-attached suture 7 and thewalls of the shaft 3 defining the head end 3 h of the shaft have alignedopenings 20 a and 20 b through which the suture 7 is threaded. (Alignedopenings may also be provided in the head module 28 in embodiments ofthe invention where the bone anchor placement device comprises a headmodule 28.) Attachment of the suture 7 along the length of the shaft 3will keep the suture 7 from becoming entangled during the bone anchorscrew 5 insertion procedure.

In the embodiment of the invention shown in FIGS. 1A-C, the length ofthe suture 7 extending out of the head end 3 h of the shaft 3 may besecured by one or more suture rings 8 mounted on the shaft 3. The suturerings 8 may be an integral part of the shaft 3 or may be clipped on asshown in FIG. 1B. After the bone anchor screw 5 is seated, the boneanchor screw 5 disengages from the mating portion 6 of the securingelement 166. The suture 7 then slips through aligned openings 20 a and20 b at the head end 3 h of the shaft 3 and through the suture rings 8,disengaging from the bone anchor placement device 1.

In another embodiment of the invention, shown in FIG. 2, a groove 23 iscut into the outer surface of the handle 2, extending in a line parallelto the longitudinal axis of the shaft 3, which is proximal to thegripping portion 26 of the handle 2. In this embodiment of theinvention, the suture 7 is enclosed within a flexible, molded sleeve 24,composed of Teflon® material, for example, which is press-fitted intothe groove 23 of the handle 2. In a further embodiment of the invention,a retaining clip 27 may be provided at the end of the sleeve 24 proximalto the gripping portion 26 of the handle 2 to prevent the suture 7 fromslipping out before the bone anchor screw 5 is screwed. The user of themanual bone anchor placement device 1 may then cut the retaining clip 27which allows the suture 7 to slide out of sleeve 24 after the boneanchor 5 is screwed into the bone.

In further embodiments of the invention, the manual bone anchorplacement device 1 may be fabricated from modules including a handlemodule and a shaft module, allowing the user to mix and match differenthandles 2 with different shafts 3 (including different head assemblies35). In the embodiment of the invention shown in FIG. 11, the handlemodule comprises the two halves 2 a and 2 b of the handle 2 (includingthe two halves 26 a and 26 b of the gripping portion 26) which areseparable from each other. In this embodiment, an old shaft 3 o may beremoved from the handle 2 upon disconnecting the force translator 12from the connector 11. A new shaft 3 nu may then be positioned withinthe handle 2. After connecting the force translator 12 of the new shaft3nu to the connector 11, the two halves 2 a and 2 b of the handle 2 aresnapped back together and the wrap-around manual bone anchor placementdevice 1 is ready for use.

In the embodiment shown in FIG. 11, interchanging the old shaft 3 o fromthe original bone anchor placement device 1 with shaft 3 nu provides theuser with the opportunity to replace a shaft 3 with an approximately 30degree upward angle with one with a 90 degree upward angle and adifferent type of head end 3 h. The modular nature of the wrap-aroundbone anchor placement device 1 thus allows users to select the type ofshaft 3 or head end 3 h/head module 28/head assembly 35 that best suitstheir needs and facilitates repairs of the device 1.

As shown in FIGS. 12 A-I, the front half 28 f and back half 28 b of thehead module 28 may also be separated by unscrewing screws at couplingregions 33. This allows the user to vary the exact configuration of thehead module 28 and head assembly 35 being used with a particular shaft3.

In the embodiment shown in FIGS. 12E, 12G, and 12H, the front half ofthe head module 28 f may also be provided with a protruding threadedelement 31. As shown in FIG. 13A, a protective cover 32 may be seated onthis threaded element 31, providing a covering for the bone anchor screw5 extending outside of the head module through opening 36 and protectingthe tip of the bone anchor screw 5 from damage before it contacts a boneinsertion site. In a further embodiment of the invention, shown in FIGS.13B and 13C, the protective cover for protecting a bone anchor screwcomprises a base 32 b for engaging the shaft 3 of the manual bone anchorplacement device 1, and a sheath 32 s coupled to the base 32 b forsurrounding and protecting the bone anchor screw 5. The sheath 32 s iscollapsible and collapses as the bone anchor screw 5 is driven intobone, uncovering the bone anchor screw. Sheath 32 s materials includeflexible plastic, rubber, thin pleated metal, and the like.

In still a further embodiment of the invention, shown in FIG. 14, themating portion 6 of the securing element 166 may be uncoupled from theengaging portion 16 of the securing element 166 without opening the headend 3 h or head module 28. In this embodiment of the invention, themating portion 6 of the securing element 166 is threaded onto a threadedelement 34 which protrudes from the engaging portion 16 of the securingelement 166 and which may be unscrewed from the engaging portion 16 ofthe securing element 166. This embodiment of the invention allowsdifferent types of mating portions 6 to be coupled to the engagingportion 16 of the securing element 166 and thus allows the user toselect a mating portion 6 of a securing element 166 that iscomplementary to any desired type of bone anchor screw 5.

Rack and Rotator Manual Bone Anchor Placement Device

As shown in FIG. 15, the rack and rotator manual bone anchor placementdevice 36, like the wrap-around device 1, is substantially pistol- orgun-shaped and comprises a handle 2 and a shaft 3. The handle 2comprises a gripping portion 26 and a lever 4 through which a user maymanually transmit linear force to the rotary force mechanism of thedevice 36. Like the wrap-around device 1, the shaft 3 of the rack androtator manual bone anchor placement device 36 comprises a first end 3 aproximal to the handle 2, and a second end, or head end 3 h, distal tothe handle 2.

As in the wrap-around device 1, the shaft portion 3 of the rack androtator manual bone anchor placement device 36 is curved to facilitatecorrect placement of the bone anchor placement device 36 to the properbone anchor screw 5 insertion site, angling upward near its head end 3h. The upward angle can be from 0 to about 90 degrees. In one embodimentof the invention, the upward angle is between about 35 and about 60degrees. In the embodiment of the invention shown in FIG. 15, the upwardangle is approximately 45 degrees. The upward angle of the shaft 3 maybe optimized to facilitate insertion of a bone anchor screw 5. The shaft3 can also be rotated 360 degrees relative to the handle portion 2 (seedashed arrow in FIG. 15).

As in the wrap-around manual bone anchor placement device 1, the rackand rotator manual bone anchor placement device 36 comprise an actionmechanism through which force on the lever 4 is transmitted to the forcetranslator 12. The action mechanism comprises lever 4, pivot 9, and theproximal end of the force translator 12. A torsional spring 10 abuts thelever 4 in the handle 2. The force translator 12 is connected to thelever 4 by a connector 11, but the position of the connector 11 relativeto the pivot 9 may be varied. As in the wrap-around manual bone anchordevice 1, the force translator 12 may be rigid (e.g., a rod) or flexible(e.g., a spring, wire, string, suture material, and the like).

Unlike the wrap-around bone anchor placement device 1, in which apushing force is transmitted to the force translator 12 by squeezing thelever 4 towards the gripping portion 26 of the handle 2, the rack androtator bone anchor placement device 36 may be configured so that eithera push force or a pull force may be transmitted through the forcetranslator 12 by squeezing the lever 4.

In the “pull” embodiment, shown in FIG. 18A, pivot 9 is positioned aboveconnector 11. In this embodiment, mechanical actuation of the lever 4,causes the force translator 12 to be subjected to tensile loading, i.e.,a pulling force, when the user squeezes the lever 4 toward the grippingportion 26 of the handle 2, and compressive loading when the userreleases the lever 4.

In the “push” embodiment shown in FIG. 18B, pivot 9 is positioned belowconnector 11 which connects force translator 12 to the lever 4.Squeezing the lever 4 in this embodiment causes the force translator 12to be subjected to compressive loading, or a pushing force.

Force translator 12 runs through the shaft 3 and transmits linear forceexerted manually on the lever 4 to a head assembly 37 positioned at thehead end 3 h of the shaft 3. Washers 21 positioned on the inside of theshaft 3 reduce the friction caused by the force translator 12 contactingthe inside surfaces of the shaft 3 (see FIG. 15).

Head assembly 37 comprises a rack 38, rotator 14 comprising at least oneprotruding portion 15 p, and a coupler 43. Head assembly 37 performs asimilar function in the rack and rotator bone anchor placement device 36as head assembly 35 does in the wrap-around device 1, translating linearforce from the force translator 12 to rotary force on a bone anchorscrew 5, but does so through a different mechanism.

As shown in FIG. 16, the distal end of the force translator 12 iscoupled to rack 38 which is positioned proximal to rotator 14. The rack38 is only able to move in the y direction while the rotator 14 is onlyable to move rotationally about the x axis. When the rack 38 moves intoan engaging position relative to the rotator 14, the teeth of rack 38mesh with the protruding portion 15 p of rotator 14, causing the rotator14 to rotate. Thus, linear force transmitted through the forcetranslator 12 translates into movement of the rack 38 along the y axiswhich in turn translates into rotation of the rotator 14 about the xaxis. The rotator 14 is coupled to coupler 43 which is capable of matingwith, or engaging, a bone anchor screw 5. Rotation of the rotator 14 istranslated into a torque applied on the coupler 43, which in turndrives, or screws, a bone anchor screw 5 into bone. Rotators 14, whichmay be used with racks 38 of the present invention, include ratchetwheels, pawls, pinions, gears, and the like.

In the embodiment of the invention shown in FIG. 16, the rotator 14comprises a ratchet wheel. In this embodiment of the invention, theinterior of the head end 3 h of the shaft 3 comprises a grooved element40 which includes an actuating groove 41 and a return groove 42. A headassembly spring 39 is also positioned within the head end 3 h and iscoupled by a first end 39 f to the inner wall of the head end 3 h of theshaft 3 distal to rack 38 and at a second end 39 s to force translator12. Squeezing lever 4 exerts a linear pull force on the translator 12which mechanically pulls the rack 38 along the actuating groove 41towards the rotator/ratchet wheel 14. When the rack 38 reaches anengaging position it engages the protruding portions 15 p of therotator/ratchet wheel 14 and rotates the rotator/ratchet wheel 14, whichin turn rotates coupler 43. Coupler 43 engages, or mates with, a boneanchor screw 5, and rotation of the coupler 43 applies a torque on thebone anchor screw 5, thereby screwing it into bone .

Release of lever 4 by the operator transmits a compressive force throughthe force translator 12 (in this embodiment, a flexible wire) to thehead assembly spring 39. A push force exerted by head assembly spring 39in response to this compressive force forces the rack back into returngroove 42 during the return stroke and disengages the rack 38 from therotator 14.

The rack and rotator rotary force mechanism shown in FIG. 16 may also beadapted for a push embodiment. In a push embodiment, compressive loadingon the force translator 12 forces the rack 38 forward to engage therotator/ratchet wheel 14 which rotates in response to this engagement.The rotation of the rotator/ratchet wheel 14 rotates coupler 43, whichin turn applies torque on a bone anchor screw 5. By varying the positionof the connector 11 relative to the pivot 9 in the action mechanism asshown in FIGS. 18A and 18B, the device 36 may be configured to be usedin either a pull or push embodiment.

In the embodiment of the invention shown in FIG. 17, the rotator 14comprises a pinion. Rotary motion from the rotator/pinion 14 istransmitted to a bone anchor screw 5 through coupler 43 which extends atleast partially through the head end 3 h of the shaft 3 through opening200 a. A push force or a pull force may be transmitted through the forcetranslator 12, as discussed above, by varying the position of theconnector 11 relative to the pivot 9 in the action mechanism of thedevice 36. A rotator spring 44 provides an opposing force to return therotator/pinion 14 to its original position. In the embodiment of theinvention shown in FIG. 17, the bone anchor screw 5 is pre-attached to asuture 7, and both the coupler 43 and the rotator/pinion 14 haveopenings through which the suture 7 is threaded. The suture 7 danglesfrom the head end 3 h of shaft 3 through opening 200 b.

FIG. 19 shows an embodiment of the invention in which the rotator 14 isa pinion, and a compressive force, or push force, is transmitted on aforce translator 12. An opposing compressive force is provided by rackspring 45, shown in cross-section in the Figure, which encircles the endof the force translator 12 proximal to rack 38 and forces the rack 38back to its original position during a release stroke.

FIG. 20 shows a further embodiment of the invention in which the forcetranslator 12 includes a first wedge member 46 at the end of the forcetranslator 12 distal to the rack 38. In this embodiment, the forcetranslator 12 is not directly coupled to the lever 4, but terminatessubstantially at the neck 47 of the head end 3 h of the shaft 3. Thetranslator 12 receives force from a tubular member 48 which terminatesin a second wedge member 49 and which is connected to the lever 4 atconnector 11. Actuation of the lever 4 pushes the second wedge member 49against the first wedge member 46 and transmits a compressive force,i.e., a push force, to the force translator 12. During the releasestroke, rotator spring 44 forces the rotator/pinion 14 back to itsoriginal position while rack spring 45 forces the rack 38 into itsinitial position.

FIG. 21 shows a further embodiment of the invention in which hydraulicor pneumatic pressure is used to exert a compressive, or push force, ona force translator 12 p. In this embodiment of the invention, the forcetranslator 12 p is a plunger which is positioned in close proximity tothe rack 38. An 0 ring 50 maintains a seal separating air or fluid inthe shaft 3 from the rack 38 and rotator/pinion 14 assembly. Hydraulicor pneumatic forces forced through the shaft 3 upon actuation of thelever 4 drive the plunger 12 p forward, transmitting linear force fromthe plunger 12 p to the rack 38, which is in turn pushed forward toengage the rotator/pinion 14. The rotator/pinion 14 rotates andtransmits rotary force to coupler 43, which applies a torque to a boneanchor screw 5. Opposing compression forces from rotator spring 44forces the rotator/pinion 14 back to its original position while rackspring 45 forces the rack 38 to return to its initial position.

As will be readily apparent to those of ordinary skill in the art, manyof the features of the wrap-around manual bone anchor placement device 1may be adapted for use with the rack and rotator manual bone anchorplacement device 36. For example, a suture 7 pre-attached to a boneanchor screw 5 may be clipped to the shaft 3 by suture rings 8 to keepthe suture 7 from becoming entangled during the bone anchor screw 5insertion procedure. Alternatively, the suture 7 may be enclosed withina flexible, molded sleeve 24 press-fitted into a groove 23 cut into thehandle 2. A retaining clip 27 provided at the end of the sleeve 24proximal to the gripping portion 26 of the handle 2 may be provided toprevent the suture 7 from slipping out of the sleeve 24 before the boneanchor screw 5 is screwed into bone.

The coupler 43 may also be configured to be adapted to a wide variety ofbone anchor screws 5. Like the securing element 166 of the wrap-aroundbone anchor placement device 1, the coupler 43 of the rack and rotatormanual bone anchor placement device 36 comprises a mating portion 43 m,which extends at least partially outside head end 3 h of the shaft 3 andwhich can be fabricated to complement different types of bone anchorscrews 5. In the embodiment of the invention shown in FIG. 19, thecoupler 43 provides a mating portion 43 m, which is a Hex-shaped recessand which seats a bone anchor screw 5 with a Hex-shaped shaft 5 a,(e.g., as shown in FIG. 5E). The mating portion 43 m of the coupler 43may be configured in any type of shape (e.g., shaft or recess) thatallows for frictional and mechanical engagement with a bone anchor screw5 having the corresponding shape (e.g., recess or shaft).

As with the wrap-around manual bone anchor placement device 1, aprotective cover 32 may be provided to protect the tip of the boneanchor screw 5 from damage before it contacts a bone insertion site, andmay be collapsible, to expose the bone anchor screw 5 only when itcontacts the bone.

As with the wrap-around manual bone anchor placement device 1, the rackand rotator bone anchor placement device 36 may be fabricated in amodular configuration to provide for the ready interchange of differenthead modules and shaft modules. For example, a shaft 3 which comprises arack 38 and rotator 14 head assembly 37 may be interchanged with a shaft3 comprising the same type of head assembly 37, but with a differentangle of curvature. Alternatively, a shaft 3 with a rack 38 and rotator14 head assembly 37 may be interchanged with a shaft 3 comprisingwrap-around head assembly 35. Similarly, different couplers 43 may beinterchanged to facilitate the use of different bone anchor screws 5.

Cup and Washer Manual Bone Anchor Placement Device

As with the previously disclosed manual bone anchor placement devices 1and 36, the cup and washer manual bone anchor placement device 52, isconfigured to be substantially pistol- or gun-shaped, having a handle 2with a gripping portion 26 and a lever 4. In the cup and washer manualbone anchor placement device 52, however, the “barrel of the gun” isformed by a driver rod 53 which extends through the handle 2 and issubstantially perpendicular along its length to the longitudinal axis ofthe gripping portion 26 of the handle 2.

FIGS. 22A and 22B show a cross-section of the cup and washer manual boneanchor placement device 52. The driver rod 53 comprises a smooth portion54 and a lead screw portion 55 with integral single or multistartthreads 55 t. The lead screw portion 55 may be integral with the smoothportion 54. Alternatively, the lead screw portion 55 may be screwed ontothreads or grooves at one of the ends of the smooth portion 52. The leadscrew portion 55 may extend from one end of the handle 2 to the otherend of the handle 2 or the lead screw portion 55 may comprise asubstantial portion of the driver rod 53. As used herein, “a substantialportion” refers to greater than 50% of the length of the driver rod 53.In a different embodiment of the invention, the driver rod 53 maycomprise a flat stock twisted into a spiral with a long pitch.

The lead screw portion 55 of the driver rod 53 further comprises anengaging element 55 e at the end of the lead screw portion 55 distal tosmooth portion 52 of the driver rod 53. The engaging element 55 eengages with a coupling member 59. The coupling member 59 comprises amating portion 59 m for mating with a bone anchor screw 5 and anengaging portion 59 e for engaging with the engaging element 55 e of thelead screw portion 55.

The position of the coupling member 59 relative to the lead screwportion 55 of the driver rod 53 may be controlled by means of a couplingmember stop 59 s. A chuck 57 provided at the barrel end 56 of the handle2 further secures coupling member 59 to the lead screw portion 55 of thedriver rod 53. Since the chuck 57 contacts both the lead screw portion55 of the driver rod 53 and the coupling member 59, any forcetransmitted through the driver rod 53 is also transmitted through thecoupling member 59 to the bone anchor screw 5. In a further embodimentof the invention, a rotatable twist lock 58 is provided, therebysupplying an additional means of securing the chuck 57 to couplingmember 59.

The rotary force mechanism in the cup and washer manual bone anchorplacement device 52 comprises cup and washer assembly 60, which includesa cup 61, a washer 62, and at least one engaging pin 65. The cup 61 iscapable of axial movement along the lead screw portion 55 of the driverrod 53, while the washer 62 is capable of both axial motion androtational motion along the lead screw portion 55.

Movement of the cup 61 is controlled by actuation of an actionmechanism, which comprises a lever 4 and a force translating member 64.The force translating member 64 comprises a first end 64 f and a secondend 64 s. The first end 64 f of the force translating member 64 iscoupled to the lever 4 at pivot point 9 while the second end 64 s iscoupled to the side of the cup 61 by means of flanges 61 f on the cup.The flanges 61 f form a yoke, which links the cup 61 to the forcetranslating member 64. The cup 61 is thus free to ride on the lead screw55 in response to movement of force translating member 64.

The cup and washer manual bone anchor placement device 52 operates onthe principle of a child's top. Applying a linear force on the lever 4by squeezing it towards the gripping portion 26 of the handle 2 actuatesthe action mechanism. Linear force is transmitted from the lever 4 tothe force translating member 64 and is transmitted to cup 61. In theembodiment of the invention shown in FIG. 23, the cup 61 comprises twoengaging pins 65 which fit into complementary holes 66 in the washer 62.The cup 61 is capable of engaging and disengaging the washer 62depending upon its direction of travel, while the washer 62 comprisesprotrusions 67 which allow it to move along and follow the thread pitchof the threads 55 t of the lead screw portion 55 of the driver rod 53.In the embodiment of the invention shown in FIG. 23A, the lead screwportion 55 may comprise grooves 66 g complementary to protrusions 67 inthe washer 62. In the embodiment of the invention shown in FIGS. 24A and24B, the engaging pins 65 of the washer 62 further comprises tangs 65 t,and the cup 61 comprises ribs 71, which constrain the motion of thewasher 62 further when the tangs 65 t of the washer 62 contact the wallsof the ribs 71.

Upon squeezing the lever 4, the translating member 64 is driven forward,moving the cup 61 forward at the same time (see dashed arrows in FIGS.22A and B). When the motion of the cup 61 is initiated, the washer 62 isforced by the lead screw portion 55's threads 55 t into contact with thecup 61. The engagement pins 65 of the cup 61 then engage with the washer62. Once engaged, the washer 62 is no longer free to rotate or spin onthe lead screw portion 55's threads 55 t. As the translational member64, cup 61, and washer 62, advance in a linear, forward direction,linear force from the force translating member 64 on the cup 61 istranslated into rotary force upon the lead screw portion 55 of thedriver rod 53, causing the driver rod 53 and the coupling member 59,which is coupled to it, to twist as the washer 62 follows the threads 55t of the lead screw portion 55. This twisting motion in turn applies atorque to a bone anchor screw 5 engaged by the coupling member 59,thereby screwing the bone anchor screw 5 into bone.

On the lever 4 return stroke, there is minimal linear force imposed uponthe coupling member 59. The cup 61 provides the washer 62 with clearanceto disengage from the engaging pins 65 of the cup 61 and to rotatefreely as the washer 62 follows the threads 55 t on the lead screwportion 55 of the driver rod 53. In a further embodiment of theinvention, shown in FIG. 22B, a return coil spring 68 may provided atthe barrel end 56 of the handle 2 to further apply a return compressiveforce on the cup 61 and translating member 64 when the lever 4 isreleased.

By incorporating a 60 degree pitch angle and 3-start thread, thecomplete seating of a bone anchor screw 5 can take place inapproximately 10 strokes of the lever 4. The number of strokes can bereduced by optimizing thread 55 t design, lever 4 stroke and/or cup61/washer 62 clearance.

It should be readily apparent to one of ordinary skill in the art thatthe engaging pins 65 may be provided on the washer 62 side rather thanthe cup 61 side and that the holes 66 may be provided in the cup 61. Thenumber of engagement pins 65 may also be varied. The engaging pins 65may be an integral part of the washer 62 or cup 61, or may be removablefrom the washer 62 or cup 61. In addition, the number of starts in themultistart thread 55 t of the lead screw portion 55 of the driver rod 53may be varied from one through what ever number is dimensionallypractical for the driver rod 53 diameter.

In a further embodiment of the invention as shown in FIGS. 22A, 22B,24A, and 25B, a cover plate 63 is provided at the rim 69 of the cup 61to contain the washer 62 within the cup 61 and to permit only minimaltravel space for the washer 62 to move in when it is drawn free from theengaging pins 65 of the cup 61.

As with the previously disclosed manual bone anchor placement devices 1and 36, the cup and washer manual bone anchor placement device 52 may beused with a bone anchor screw 5 with a pre-attached suture 7 which maybe enclosed within a sleeve 24 press-fitted into a groove 23 cut intohandle portion 2. The mating portion 59 m of the coupling member may beconfigured to mate with a variety of bone anchor screws 5, and maycomprise a shaft configured in a shape complementary to a recess in abone anchor screw 5 or may comprise a recess complementary to a shaft ina bone anchor screw 5. As in the previously disclosed devices 1 and 36,the cup and washer manual bone anchor placement device 52 may include amodular design allowing for the interchange of different types ofcoupling members 59. The handle portion 2 may also be configured toinclude two separable halves which are able to snap-fit together,allowing removal of one driver rod and/or cup and washer assembly andreplacement with another.

Self-Tapping Bone Anchor Screw

FIG. 26 shows a bone anchor screw 5 according to one embodiment of theinvention. As shown in the FIG. 26, the threads of the bone anchor screw5 are of buttress form. The forward face 72 of the screw thread isperpendicular to the longitudinal axis 73 of the bone anchor screw 5while the back face 74 of the screw thread is at an acute angle relativeto the longitudinal axis 73 of the bone anchor screw 5. The threadsextend to the tip of the screw shank 75, reducing the amount of torquerequired to seat the bone anchor screw 5. In one embodiment of theinvention, the back face 74 of the screw thread is at a 30 degree anglerelative to forward face 72 of the screw thread.

The base 76 of the bone anchor screw 5 shown in FIG. 26A has an eyelet77 which is circular and has micropolished edges. In another embodimentof the invention, the eyelet 77 at base 76 may be tear-drop shaped, orellipsoidal. Other configurations may be used so long as the edges arerounded so as not to damage the suture 7. Micropolishing the eyelet 77rounds the edges and reduces load to the suture 7 that may be caused bytwisting (torsional load) during insertion, the user tugging on thesuture 7 to test seating of the screw, and bodily movement while theanchor screw and suture are in place.

According to a further embodiment of the invention, kits including thedisclosed self-tapping bone anchor screw may be provided for theconvenience of the user. In one embodiment of the invention, a kit isprovided, comprising at least one of: 1) a flexible, molded sleeve 24for enclosing a suture 7, 2) a retaining clip 27 for preventing thesuture 7 from slipping out of the sleeve 24, 3) a buttress-shaped boneanchor screw 5 comprising a micropolished eyelet 77 for receiving thesuture 7, and 4) suture 7 material, which may or may not, bepre-attached to the bone anchor screw 5. The kit may comprise any one ofthese elements or combinations thereof.

Having thus described certain embodiments of the present invention,various alterations, modifications, and improvements will be obvious tothose skilled in the art. Such variations, modifications andimprovements are intended to be within the spirit and scope of theinvention. The materials employed, as well as their shapes anddimensions, generally can vary. Accordingly, the foregoing descriptionis by way of example only and is not intended to be limiting.

What is claimed is:
 1. A manual bone anchor placement device,comprising: a manually-actuatable lever; a resilient element; a forcetranslator comprising a distal end and a proximal end, the distal endbeing coupled to the lever and the proximal end being coupled to theresilient element, the force translator transmitting a force exerted onthe lever to the resilient element; and a rotator coupled to theresilient element, the rotator receiving force from the resilientelement and rotating in response thereto.
 2. The manual bone anchorplacement device of claim 1, further comprising a securing elementcoupled to the rotator, the securing element mating with a bone anchorscrew and rotating when the rotator rotates, thereby applying a torqueon the bone anchor screw and placing the bone anchor screw into bone. 3.The manual bone anchor placement device of claim 2, wherein the securingelement comprises teeth and wherein the rotator comprises at least oneprotruding portion capable of engaging the teeth.
 4. The manual boneanchor placement device of claim 3, wherein the at least one protrudingportion comprises a pawl.
 5. The manual bone anchor placement device ofclaim 1, further comprising a handle including a groove for receiving asuture attached to a bone anchor screw.
 6. The manual bone anchorplacement device of claim 1, further comprising a connector with a firstend and a second end, the first end coupled to the force translator, andthe second end coupled to the lever.
 7. The manual bone anchor placementdevice of claim 6, wherein the lever comprises a slot for receiving theconnector.
 8. The manual bone anchor placement device of claim 6,wherein the lever further comprises a pivot, the connector beingpositioned below the pivot, and the force translator receiving a pushforce when the lever is manually actuated.